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FDA Intends for Essure Device to Have Black Box Warning Label

October 18, 2016 By: Burnetti, P.A.

The U.S. Food and Drug Administration intends to require Bayer AG’s Essure contraceptive implant to have a “black box” warning label, which is the strongest U.S. safety warning label. The FDA has also asked the drugmaker to conduct more studies on the birth control device after thousands of safety complaints.

The “black box” warning would include labeling serious risks associated with the device that has been promoted as an alternative to permanent birth control surgeries. Thousands of women have pushed for the ban of the device after suffering serious health complications, including:

Perforation of the uterus

Perforation of the fallopian tubes

Severe allergic reactions

Chronic pelvic pain

Hemorrhaging

Unexpected pregnancy (Risks to the mother and baby are unknown)

If you have been injured by Essure or another medical device and would like more information about how to file a dangerous medical device lawsuit, product liability lawyersat Burnetti, P.A. may be able to help. Call 1-888-BURNETTI for a free case review orinitiate a chat with our online operator.

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